A Remission Induction Therapy and Risk-oriented Postremission Strategy for Adult Acute Myelogenous Leukemia (AML)

Summary

The study was set up to assess: 1. Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures, followed by morphological, cytogenetic and molecular monitoring of remission. 2. A risk-oriented postremission therapy: HR patients will be electively submitted to allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated donor/cord blood; ablative/non-ablative conditioning according to national and local protocols and guidelines). Provided sufficient blood stem cells were previously collected (\>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous blood stem cell-supported high-dose cytarabine-based therapy. * HR/SR patients unable to be randomized because of inadequate blood stem cell yield will receive intermediate-dose consolidation; patients aged \>65 years will be treated with age-adapted therapy.

Timeline

Start

2006-11

Primary completion

2015-07

Completion

2015-12

Outcome

Missed primary endpoint

paper CR rates after 2 induction courses were comparable between ICE (80.8%) and sHD (83.6%; P = .38). PMID 30948365 ↗

Publications

• Caprioli C, Lussana F, Salmoiraghi S, Cavagna R, Buklijas K, Elidi L, Zanghi' P, Michelato A, Delaini F, Oldani E, Intermesoli T, Grassi A, Gianfaldoni G, Mannelli F, Ferrero D, Audisio E, Terruzzi E, De Paoli L, Cattaneo C, Borlenghi E, Cavattoni I, Tajana M, Scattolin AM, Mattei D, Corradini P, Campiotti L, Ciceri F, Bernardi M, Todisco E, Cortelezzi A, Falini B, Pavoni C, Bassan R, Spinelli O, Rambaldi A. Clinical significance of chromatin-spliceosome acute myeloid leukemia: a report from the Northern Italy Leukemia Group (NILG) randomized trial 02/06. Haematologica. 2021 Oct 1;106(10):2578-2587. doi: 10.3324/haematol.2020.252825.
• Gianfaldoni G, Mannelli F, Intermesoli T, Bencini S, Giupponi D, Farina G, Cutini I, Bonetti MI, Masciulli A, Audisio E, Ferrero D, Pavoni C, Scattolin AM, Bosi A, Rambaldi A, Bassan R. Early peripheral clearance of leukemia-associated immunophenotypes in AML: centralized analysis of a randomized trial. Blood Adv. 2020 Jan 28;4(2):301-311. doi: 10.1182/bloodadvances.2019000406.
• Bassan R, Intermesoli T, Masciulli A, Pavoni C, Boschini C, Gianfaldoni G, Marmont F, Cavattoni I, Mattei D, Terruzzi E, De Paoli L, Cattaneo C, Borlenghi E, Ciceri F, Bernardi M, Scattolin AM, Todisco E, Campiotti L, Corradini P, Cortelezzi A, Ferrero D, Zanghi P, Oldani E, Spinelli O, Audisio E, Cortelazzo S, Bosi A, Falini B, Pogliani EM, Rambaldi A. Randomized trial comparing standard vs sequential high-dose chemotherapy for inducing early CR in adult AML. Blood Adv. 2019 Apr 9;3(7):1103-1117. doi: 10.1182/bloodadvances.2018026625.

Drugs

Indications